Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial

• Published in: The American heart journal Vol. 237; pp. 90 - 103
• Main Authors: Handberg, Eileen M., Merz, C. Noel Bairey, Cooper-Dehoff, Rhonda M., Wei, Janet, Conlon, Michael, Lo, Margaret C., Boden, William, Frayne, Susan M., Villines, Todd, Spertus, John A., Weintraub, William, O'Malley, Patrick, Chaitman, Bernard, Shaw, Leslee J., Budoff, Matthew, Rogatko, Andre, Pepine, Carl J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2021; Elsevier Limited
• Subjects: Acute coronary syndromes; Angina; Angina pectoris; Angiography; Angiotensin; Angiotensin-converting enzyme inhibitors; Asymptomatic; Biomarkers; Cardiac catheterization; Cardiovascular disease; Consents; Coronary artery; Coronary artery disease; Data capture; Enzyme inhibitors; Grants; Guidelines; Heart attacks; Heart diseases; Hospitalization; Intubation; Ischemia; Medical imaging; Pain; Patients; Peptidyl-dipeptidase A; Quality of life; Resource consumption; Resource management; Scholarships & fellowships; Signs and symptoms; Statins; Strategy; Stroke; Symptom management; Womens health; Los Angeles California; United States > US; California
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2021.03.011

Approximately half of all women with anginal symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA) referred for coronary angiography have elevated risk for major adverse cardiac events (MACE), poor quality of life and resource consumption. Yet, guidelines focus on symptom management while clinical practice typically advocates only reassurance. Pilot studies of INOCA subjects suggest benefit with intensive medical therapy (IMT) that includes high-intensity statins and angiotensin converting enzyme inhibitors (ACE-I) or receptor blockers (ARB) to provide the rationale for a randomized pragmatic trial to limit MACE. The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) in 4,422 symptomatic women with INOCA (NCT 03417388) in approximately 70 United States sites. The hypothesis is that IMT will reduce the primary outcome of first occurrence of MACE by 20% vs. UC at ∼2.5 year followup. Secondary outcomes include quality of life, time to return to “duty”/work, healthcare utilization, angina, cardiovascular death and individual primary outcome components over 3 years follow-up. The study utilizes web-based data capture, e-consents, single IRB and centralized pharmacy distribution of strategy medications directly to patients’ homes to reduce site and patient burden. A biorepository will collect blood samples to assess potential mechanisms. The results of this trial will provide important data necessary to inform guidelines regarding how best to manage this growing and challenging population of women with INOCA.